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A shortage of albuterol is about to get worse, especially in hospitals | CNN

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CNN
—

An ongoing shortage of a medicine commonly used to treat people with breathing problems is expected to get worse after a major supplier to US hospitals shut down last week.

Liquid albuterol has been in short supply since last summer, according to the American Society of Health-System Pharmacists. It has been on the US Food and Drug Administration’s shortages list since October. The news of the plant shutdown worries some doctors who work with patients with breathing problems such as asthma.

“This is definitely concerning, especially as we are coming out of the respiratory season where we had a big demand with RSV, Covid-19 and flu, and are now heading into spring allergy season when a lot of kids and adults experience asthma symptoms,” said Dr. Juanita Mora, a national volunteer medical spokesperson for the American Lung Association and an allergist/immunologist based in Chicago. “This is a life-saving drug and being able to breathe is vital for everyone.”

The manufacturer that recently shut down, Akorn Operating Company LLC, had filed for Chapter 11 bankruptcy in May 2020.

It was the only company to make certain albuterol products used for continuous nebulizer treatment. It’s a staple in children’s hospitals, but had been out of stock since last fall. Without that particular form of the product, hospitals have had to scramble to find alternatives.

“Members are either forced to compound it themselves to make the product or go to an outside third party source who is compounding the product,” said Paula Gurz, senior director of pharmacy contracting with Premier Inc., a major group purchasing company for hospitals.

With the Akorn shutdown, Gurz said products from the one remaining major domestic source of liquid albuterol, Nephron Pharmacuticals, have been on back order. Nephron just started shipping albuterol last Friday, Gurz said, but to get back on track, “it’s going to be an uphill climb.”

Hospitals around the country said they’re watching the supply chain – and their current stock – closely. There’s concern they might have to delay discharging patients because they don’t have enough medicine, or that they may see more ER visits for people with breathing problems who don’t have access to medicine.

Dr. Eryn Piper, a clinical pharmacist at Children’s Hospital of New Orleans, said her hospital has been largely unaffected so far, but for months she has heard about retail pharmacies and other health systems that have had issues with albuterol shortages.

“The big problem we’ve been hearing about is inhalation solutions, not really the inhalers, it’s more like the solutions that go into the nebulizer machines for inhalation that the patients breath in,” said Piper.

Without the larger Akorn product, staff at Lurie Children’s Hospital in Chicago had to squeeze out the albuterol contents from smaller packages.

It’s “time-consuming and labor-intensive as it takes opening 40 containers to equal 20 mL (each patient on continuous albuterol requires 3-5 syringes per day),” said hospital spokesperson Julianne Bardele in an email.

When Nephron was unable to meet demand due to manufacturing issues, Bardele said Lurie had to make another temporary switch to a different concentration and use an alternative liquid bronchodilator, levalbuterol.

Most hospital pharmacies are aware of supply issues for many medicines, particularly pediatric medicines, said T.J. Grimm, the director of retail and ambulatory services at University Hospitals Cleveland Medical Center, and they try to keep a higher stock – especially of the less expensive medicines like albuterol.

“Just so we can cover situations like this,” Grimm said.

Grimm said his system has albuterol supply for a couple of months still, but he’s frustrated and concerned about the supply chain.

“When you have supply chains that are just-in-time, it can create some issues with when something goes off,” Grimm added. “There’s the short-term crisis we all have to get through and then there’s a longer term. We need to think about these things a little more strategically, especially with our kids.”

Jerrod Milton, the chief clinical officer at Children’s Hospital Colorado, said they’ve been paying close attention to the albuterol shortages for many months. The hospital has experienced shortages in the past, and has continued to implement protocols to conserve doses.

“Challenges are what we deal with when it comes to pediatric medicine. We consider most of the kids that we take care of as somewhat therapeutic orphans,” Milton said. “It’s just another one of the myriad of shortages that we have to deal with, I guess.”

Jessica Daley, the group vice president of strategic sourcing for Premier, said that she doesn’t anticipate that the albuterol shortage will be an ongoing problem for years, but when the market has only a handful of suppliers, “it makes for a very tight market, a very concerning market right now.”

Daley said there are things hospitals can do to help, such as protocol changes, making products on site and finding different suppliers.

The Children’s Hospital Association stepped in to help when it heard from members having difficulty finding enough supply. The association worked with STAQ Pharma, a facility that provides compounded pediatric medication, to start production on batches of albuterol for children’s hospitals in the sizes they needed.

“We’ve been creative and trying to work proactively. So when we think there’s going to be a problem, we’re trying to plan ahead,” said Terri Lyle Wilson, director of supply chain services for the Children’s Hospital Association.

STAQ should be at full production by May, so hospitals will have a steady, stable supply ahead of the next season in which respiratory viruses are in wide circulation, the association says.

Daley at Premier said that in an ideal world, there would be more suppliers of these products, particularly with generic drugs, so that when there is a problem with one, the market could handle it. When there is a concentration of manufacturing with a small number of suppliers, it is very hard to recover, she said.

“We really advocate for diversity and supply to prevent types these types of issues,” Daley said. “Meaning at least three globally, geographically diverse suppliers that are supplying the market with sufficient products.”

For patients, Piper at Children’s Hospital of New Orleans said they are encouraging patients with breathing problems to take precautions and avoid asthma triggers if possible. She said if a patient’s usual pharmacy runs out, it’s also good to check with a doctor to see if there is another medication that’s available.

Inhalers don’t seem to be impacted by the shortage so far, but Daley said if people panic about the lack of albuterol for hospitals, that could change.

“Albuterol is one of those things that if there’s a patient who needs it, you want to have it all the time. So there’s always that potential for the market to respond and react in a way that that will then create downstream shortages of other sizes or presentations of a product,” Daley said.

To avoid that problem, Milton at Children’s Hospital Colorado said it’s simple: “Talk to a provider and see if there are alternatives,” Milton said. “And please don’t hoard.”

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How to stop dieting, according to people who have done it | CNN

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Editor’s Note: This is part of an ongoing series that takes a closer look at eating disorders, disordered eating and relationships with food and body image.

CNN
—

Ending cycles of dieting and learning to accept the body you are in sounds great, but it may feel a bit like a fairytale.

How can you control how you eat without counting calories? How should you stop planning for the day when you are thinner? How do you wake up one day without those shameful, mean thoughts knocking at the door to your brain?

It’s hard, said Bri Campos, a body image coach based in Paramus, New Jersey. The goal might not be fully celebrating your body or releasing yourself from all the negative thoughts about weight that comes from diet culture, she said. It could mean just making progress toward feeling less shame or self-criticism.

Diet culture is the widespread societal messages that small bodies are better, larger bodies are shameful and restricted eating is the key to an “acceptable” body. Ascribing to those messages is harmful to people of all body types, especially considering it can encourage eating disorders and make recovery therefrom even more difficult, according to the National Eating Disorder Association.

The promise of attaining (and retaining) the ideal body is hollow, as dropping weight drastically in a short period is likely to be followed by a person gaining it back again. Slow, sustained changes are often more successful, according to a 2017 study. And while some studies do recommend losing weight to reduce the risk of conditions such as heart disease and cancer, it’s also true that health is determined by many factors — shame doesn’t help.

There are ways to unlearn diet culture, Campos said. The process is different for each person, but it can help to find community with other people with similar goals, she added.

Here are several stories of people trying to reject diet culture and what they have found in their journeys along the way.

Shanea Pallone started to question her experience with diet culture after a doctor body-shamed her at an appointment. It’s been hard to be a patient in a medical system that has caused her great harm. “I am actively being harmed by providers who don’t see me as more than my weight on the scale,” Pallone said.

But Pallone, who lives in Houston, Texas, also works as a nurse; her job has required her to assess her patients’ weights, mark if they were considered obese on their medical charts and teach them the same dieting tactics she was trying to unlearn herself, she said.

Pallone recalled constantly asking herself, “How do I navigate my own care and giving good care and still work on unpacking some of the ways diet culture still sinks in?” Her answer included going back to research that showed that dieting wasn’t effective — and confirmed she could live healthfully and provide care without shame.

Learning about intuitive eating — an eating philosophy that relies on the body’s natural hunger and fullness cues — helped her in both her personal and professional journeys.

Changing her thinking doesn’t mean that intrusive thoughts about food and diet completely truly go away, but it has gotten easier to see them and try to quiet them, Pallone said. Now Pallone works to help her patients meet their health goals in a way that doesn’t keep them from the foods they love eating or make them feel like they’ve failed, she said.

But while she has been able to have some meaningful impacts on her patients, she had to accept she could not rescue everyone from diet culture.

“It is really hard to walk away from a woman in her 80s, who is moving toward hospice, who (is) like, ‘It’s really ok that I’m losing weight, I’ve always been a little chunky,’” Pallone said.

Amanda Mittman said the process of shedding diet culture is ongoing.

Amanda Mittman, a registered dietitian in Amherst, Massachusetts, began moving away from diet culture after her son was born. She couldn’t bring herself to return to a restrictive way of eating as a new mother, but still felt shame around the weight she hadn’t lost postpartum, she said.

“We’re all still swimming in the same toxic soup,” she said.

Mittman’s first step was to learn to identify diet culture around her, across entertainment media, in advertisements and even in conversations with friends and family, she said.

And once she saw it — like pulling the curtain back on the Wizard of Oz — she found she couldn’t go back to how she saw things before.

This didn’t mean she was ready to give up on dieting and completely accept her body. Diets had always offered her a magical solution: lose weight and you can have everything you’ve ever wanted. It was scary to give up on that dream — and to face the possibility that, in living differently, she might gain weight instead of losing it.

But as she found a community free of diet culture and moved her social media feeds to not value weight loss, Mittman said accepting the grief and mourning that comes with giving up on those goals became a big part of her process.

“I still have the thoughts of ‘wouldn’t it be great if I could lose weight?’” she said. But she reminds herself, “We have been down that road and that’s just not available to me anymore.”

The work to accept her body and love herself isn’t glamorous, she said. There’s “no cap and gowns, you don’t graduate — this is constant work,” Mittman said. “But it gets easier all the time.”

Sandra Thies' mirror was a big trigger and now is part of her healing.

After years on her college varsity rowing team and trying to shape her body to fit expectations, Sandra Thies found herself a little lost without a strict diet and exercise routine.

“The easy way out is to go on another diet, to buy into diet culture online, to restrict your eating,” Thies said. “It’s the easy way to feel that you have control.”

Much of that desire for control would come out around reflective surfaces, she said.

Whether it was the windows she walked by, mirrors in her work bathroom or even at home when she got out of the shower – all were places for Thies to poke and prod at her body, to see if she needed to work out or if she could give herself a little extra at dinner. And days wrestling with her reflection would lead to nights spent staring up at the ceiling, thinking about what she could do better the next day to get closer to her “ideal” body.

Thies, now an intuitive eating counselor in Kelowna, British Columbia, came across the concept in college and remembers thinking, “wouldn’t it be nice to be at peace with food and your body?” Four years later, she feels like she’s still learning how to move in a way that feels good, how to eat what her body needs and how to stand in front of her reflection without picking it apart.

But the mirror has actually become part of her solution, she said.

She has questions now written on her mirror at home: “What is the feeling? Where do you feel it in your body? How bad is it? Can we sit in this discomfort? What do you need in the moment?”

She now tries to take time to sit with those feelings. Sometimes, she can get through answering all the questions. But on the days she can’t, Thies said she gives herself permission to do what she can to keep her self-talk positive.

“I think about my body and food very frequently,” Thies said. “But the voice that I use has really changed. It leaves me feeling confident and empowered rather than broken down.”

Dani Bryant said she saw her own body in the women that came before her.

Dani Bryant thought her experiences with her body would threaten to her creative dreams, but instead they turned out to be an avenue to get there.

As a kid passionate about theater, Bryant heard similar messages from her directors, chorus teachers and costumers: You are so talented, but your body has to be smaller if you want to make it big.

She was only a 9-year-old when she first showed signs of disordered eating. By her sophomore year of college pursuing a career in theater, she had developed anorexia, Bryant said.

As part of Bryant’s recovery, she began writing and developed a theater company in Chicago centered around the experiences of body issues and disordered eating, Bryant said. There she found the support she felt was key to her developing relationship with her body.

“My healing is so much in sharing the lived experience, building community around it and that slow unlearning,” she said.

Bryant said finding a photo of her family coming to the US gave her better perspective on her own body.

One big moment in Bryant’s healing journey came when she went with her mother on a trip to Ellis Island in New York City, where they happened across a photograph of her family arriving in the United States generations ago.

In the photo, she saw her great grandmother, whose body was shaped just like her grandmother’s, her mother’s and her own, Bryant said.

There she realized her body was more than her choices or her dieting — it was the result of her family, genetics and her history.

She wished she could go back to the little girl she once was to show her that picture and ask her to stop fighting the “unwinnable war” for a smaller body she was never meant to have, she said.

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Ohio, Pennsylvania offer health services following train derailment, but some residents feel skeptical | CNN

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Darlington Township, Pennsylvania
CNN
—

The municipal building in tiny Darlington Township, Pennsylvania, was buzzing with activity on Wednesday afternoon as a stream of locals arrived seeking information on health screenings, chemical exposures and well testing.

Darlington, home to about 1,800 people, sits just over the border from East Palestine, Ohio, the site of a catastrophic train derailment and controlled burn of toxic chemicals that sent black smoke billowing over the area for days in early February. Residents here say the wind blew acrid smoke into their homes and coated their cars with a fine ash. State and federal officials gave East Palestine residents the all-clear to return to their homes days later.

But residents in both places are now wondering whether their water is safe to drink and their air safe to breathe. The characteristic floral, fruity odor of butyl acrylate still permeates some homes and wafts up from some of the impacted streams that run through the town. Some say they’re experiencing symptoms – cough, headaches, rashes, watering eyes and dripping noses – that might be related to a chemical exposure.

Government-run community resource centers and health clinics have opened in East Palestine and Darlington to answer residents’ questions and connect them to any care they might need. More than 140 people have come to the clinic in East Palestine since it first opened on February 21, according to the Ohio Department of Health. The Darlington center opened February 28, and more than 200 people visited in its first two days, according to the Pennsylvania Department of Health.

Still, some residents are skeptical of the clinics, and the response overall. While many residents who live near the derailment site are following the testing for chemicals in the air and water, what they really want to know is whether they’ve had chemicals from the accident in their bodies, and whether those chemicals have impacted their health.

They’re swapping information online, and seeking out blood tests they hope will identify potential problems. Some are seeking out medical care so there’s a record of their symptoms.

On the advice of a lawyer, Ron Book and his wife came to the East Palestine Health Assessment Clinic on Wednesday afternoon to have their illnesses documented. Book says since the derailment, his nose has been running constantly. He has a sore throat, and he feels stuffy.

“It’s like I have a cold, but I don’t have a cold,” he said.

Book said he saw a doctor who took his vitals and advised him to keep up with the regular blood work that he needs for his ongoing treatment for prostate cancer. He was inside for about 45 minutes, and said the experience was helpful, and about what he expected.

“They can’t heal you,” Book says, “because nobody knows about this chemical.”

At the Darlington center, tables were staffed with experts to answer questions about the chemicals involved in the train derailment, free well and air testing for residents, and potential impacts to area farms.

There were pamphlets on how to manage stress following a disaster and mental health counselors, as well as Zuko, a 3-year-old Great Dane therapy dog.

Residents are also invited to take a nine-page questionnaire to contribute data to a newly launched Assessment of Chemical Exposure, or ACE, study, which is being conducted by the federal Agency for Toxic Substances and Disease Registry. Health investigators can use their data to inform a study into the health effects associated with the chemical exposures after the derailment.

People could see a doctor, or get referrals for a primary care physician.

“I think approximately 40% of people sought some sort of clinical evaluation,” said Nate Wardle, who is the special response project manager for the Pennsylvania Department of Health.

Wardle said when they opened the clinic, they weren’t sure what to expect – whether residents would be angry that it took more than three weeks to get them these services. So far, he said, people have been grateful and eager to get the help.

Jim Denes, who is 71, came to the health clinic in Darlington Township on Wednesday. He said he lives less than 2 miles from the accident site. On Friday of last week, Denes said he felt awful.

“I was just miserable. I was trying to cough up stuff, I couldn’t,” Denes said. “My eyes were all runny and watery.”

He said he took a Covid-19 test, but it was negative.

Denes said he’s extremely tired and had to drag himself to the clinic, but he’s glad he did. The doctor he saw diagnosed him with bronchitis and prescribed an antibiotic. The clinic was a lot closer than his regular doctor in Ellwood City, and he was able to walk in and be seen without a wait.

Denes said the doctor told him he couldn’t say whether it was related to the chemicals that were spilled or not.

Some residents said they have no interest in going to government-run health clinics.

“I honestly, at this point, don’t know who’s working with who and I really just don’t trust anything that has to do with the government right now,” said Giovanni Irizarry, whose family lives within a mile of the train derailment site.

In the evening hours of February 3, his wife Ashley Irizarry was driving to work when she noticed she could see thick black smoke hanging in the air, even though it was dark. Eventually, she saw the raging fire along the railroad tracks.

That night, Ashley had a red rash on her cheeks, her eyes were burning and red and a metallic chemical smell had burned her nose and throat. On Saturday, Giovanni said, his lips burned like he’d had scalding hot soup. Giovanni’s mother, who was living with them, developed a cough so severe she couldn’t catch her breath. The Irizarrys evacuated on Sunday to Boardman, Ohio, about 15 miles away.

They returned home on Saturday, February 11, in anticipation of school restarting on Monday.

As soon as they got close to town, Giovanni said, “I immediately felt my lips like start that burning sensation.”

He and his mom started coughing. His wife and kids developed debilitating and unrelenting headaches. After the kids came home from school on Monday, both started vomiting.

Ashley says she has taken the family to their primary care doctor, an urgent care and the hospital.

“It was not getting better,” she said.

Medical records reviewed by CNN show Ashley was prescribed a steroid and given a chest X-ray due to “toxic effects of gas exposure.” Her son was also diagnosed with chemical exposure.

When the doctors looked into her nose and throat they told her ” ‘Your mucous membranes are all pale. Like they were burned,’ but they didn’t know what to do at this time,” Ashley said in an interview with CNN on Wednesday.

On public Facebook groups, residents are sharing names of providers who will order blood testing for chemical exposures, which isn’t something either of the government-run clinics is doing currently. Some have even tried to do their own research to try to identify the medical codes needed to order tests for specific chemicals in the blood from large labs.

Instead of going to the government health clinic, on Wednesday, Ashley went to see their chiropractor, Richard Tsai, who has been ordering certain blood tests for existing patients who think they have having health problems connected to chemical exposures from the derailment.

Tsai’s practice, Blackhawk Chiropractic, is right next door to the Darlington Township community resource center and clinic that was opened by the Pennsylvania Department of Health and other state agencies this week.

The tests Tsai orders are general and standard in medical care – a test called a complete blood count, which measures levels of red cells, white cells, and clotting factors in the blood; and a test called a basic metabolic panel, which measures blood sugar, electrolytes, and kidney function. If his patients ask for it, he also orders a more specialized test that measure exposure to the chemical benzene. In the past two days, he estimates about 15 patients have asked him for blood testing.

Tsai, who lives in East Palestine, says he’s been frustrated by the government’s response.

“We shouldn’t be having to do this,” Tsai said, in an interview with CNN on Wednesday.

“Why are people having to figure this out on Facebook? These people need to know where to go and what’s available.”

Dr. Bruce Vanderhoff, director of the Ohio Department of Health, pushed back against the idea that the government wasn’t giving people enough information. He said that during the course of the medical assessment at the health clinic, the clinic physician might make recommendations for further testing, but that would be done by the person’s regular doctor.

If people don’t have a doctor that they see regularly, Vanderhoff said they are trying to help residents find one.

Vanderhoff said it would be important for the primary care providers to continue to monitor changes in a patient’s overall health.

“Because when we look at the chemicals involved, especially the primary chemical vinyl chloride, there is simply not a blood test that we can do or a urine test that we can do that would say ‘Aha! You had an exposure,’ ” Vanderhoff said. “That would be great, but that’s just not the case.”

Tsai, who lives in East Palestine, said that he’s legally able to order medical tests, so he does, within limits. “Why wouldn’t you do that?” he said.

Dr. Erin Haynes, the chairperson of the department of epidemiology and environmental health at the University of Kentucky, says she thinks it’s sound for residents to seek out common blood tests.

In an email to CNN, Haynes said in addition to a complete blood count and basic metabolic panel she would add a liver function test, since vinyl chloride, one chemical that was on the train, can damage the liver.

But Haynes says trying to test for specific chemicals may be a step too far.

“Testing for chemical exposure at this point is a difficult,” says Haynes, who has helped impacted communities investigate environmental exposures. “The high levels are now gone, and we aren’t exactly sure what to measure in blood or urine since we don’t know what chemicals formed during the fire. There are suspects, but not clear answers yet.”

Haynes said it would be ideal to collect blood and urine samples now, but store them for later testing, but this would be difficult for a local clinic to do.

Overall, Haynes says the government’s response to chemical spills like this one leaves something to be desired.

“The community is in dire need of an organized and coordinated health monitoring study that includes exposure assessment,” said Haynes, who hopes to bring such a study to the area soon.

Down the road, she says, there’s still a lot to learn about the health impacts of environmental exposures to toxins.

“We also need more research on what these chemicals do and methods for rapid testing,” Haynes said. “Communities with railroad must know what is moving through their community, when and how much. They also must receive training on how to safely respond when a disaster occurs.”

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Eli Lilly to cut insulin prices, cap costs at $35 for many people with diabetes | CNN

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CNN
—

Eli Lilly announced Wednesday a series of price cuts that would lower the price of the most commonly used forms of its insulin 70% and said it will automatically cap out-of-pocket insulin costs at $35 for people who have private insurance and use participating pharmacies.

Lilly says it will also expand its Insulin Value Program, which caps out-of-pocket costs at $35 or less per month for people who are uninsured.

President Joe Biden heralded the announcement as “a big deal.”

“For far too long, American families have been crushed by drug costs many times higher than what people in other countries are charged for the same prescriptions. Insulin costs less than $10 to make, but Americans are sometimes forced to pay over $300 for it. It’s flat wrong,” Biden said in a statement on Wednesday.

The President also urged other pharmaceutical companies to cut insulin prices.

“Last year, I signed a law to cap insulin at $35 for seniors and I called on pharma companies to bring prices down for everyone on their own. Today, Eli Lilly did that. It’s a big deal, and it’s time for other manufacturers to follow,” Biden said.

Eli Lilly says it will cut the list price of its nonbranded insulin to $25 a vial as of May 1, making it the lowest list-priced mealtime insulin available. Its current list price is $82.41 for a vial.

Lilly will also lower the list price of Humulin and its most commonly prescribed insulin, Humalog, in the fourth quarter of 2023. The current list price of a Humalog vial is $274.70, and the new list price will be $66.40. For people with commercial insurance who use participating pharmacies, the out-of-pocket costs will now be capped at $35.

Although insulin is relatively inexpensive to manufacture, the cost has been a problem for many Americans for years. At least 16.5% of people in the US who use it report rationing it because of cost.

The average price of insulin nearly tripled between 2002 and 2013, the American Diabetes Association says. GoodRx research shows that the trend has continued, with the average retail price of insulin rising 54% between 2014 and 2019.

Demand for insulin has grown significantly as diabetes has become the fastest-growing chronic disease in the world, a 2022 study found.

In the US alone, the number of adults with diabetes has doubled over the past 20 years, and more than 37.3 million people now have it, according to the US Centers for Disease Control and Prevention. Another 96 million Americans – 38% of the population – have prediabetes, a condition in which blood sugar levels are higher than normal but not high enough for a diagnosis of type 2 diabetes. This can often lead to diabetes.

People with diabetes rely on insulin because their bodies have stopped producing enough of this hormone or aren’t using it efficiently to convert food into energy.

When a person eats, their body breaks down food, mostly into sugar. This sugar enters the bloodstream, and that signals the pancreas to release insulin, which works like a key that allows the sugar to energize cells. But if diabetes keeps sugar in the bloodstream for too long, it can lead to serious problems like kidney disease, heart problems and blindness. In 2019, diabetes was the seventh leading cause of death in the US, according to the American Diabetes Association.

This year’s Inflation Reduction Act capped insulin costs for seniors who get their health coverage through Medicare Part D at $35 a month. Congressional Democrats pushed to extend that price cap to people covered by private insurance, but Republicans stripped that measure from the bill.

The US Food and Drug Administration’s approvals of generic insulin and biosimilars – drugs similar to original versions that can be made differently or with slightly different substances – have driven down the price at least somewhat, according to GoodRx.

Some states have taken matters into their own hands. Twenty-two states and the District of Columbia have price caps ranging from $25 to $100 for insulin as well as diabetes supplies and devices – but that’s only for people covered by insurance plans regulated by those states.

“While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change,” David A. Ricks, Lilly’s chair and CEO, said in a statement. “The aggressive price cuts we’re announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap.”

Lilly has been one of the biggest players in the US insulin market since it became the first company to commercialize the lifesaving drug 100 years ago. The company said that its price changes should make a difference, but more is needed to help all Americans with diabetes – 7 out of 10 don’t use the company’s insulin.

The Medicare Part D cap “should be the new standard in America,” Ricks said on CNN This Morning on Wednesday.

He called on the insurance industry, policymakers and other manufacturers to join them in making insulin more affordable.

“We call on everyone to meet us at this point and take this issue away from a disease that’s stressful and difficult to manage already – to take away the affordability challenges,” Ricks told CNN’s Don Lemon.

Other companies have cut insulin costs over the years.

In 2019, Sanofi created the Insulin Valyou Savings Program, which charged patients $99 a month for insulin, regardless of income. In 2021, Novo Nordisk created a similar program called My$99Insulin.

Also that year, Novo Nordisk collaborated with Walmart to sell private-label analog insulin at a deep discount. Walmart said its ReliOn NovoLog vials and FlexPens save customers 58% to 75% off the cash price for branded insulin.

For Eli Lilly insulin, the new price cap will automatically apply at most pharmacies with no additional action from the patient. Otherwise, a coupon will be available for patients to use at the remaining 15% of pharmacies where the electronic system does not allow for the automatic price drop, Ricks said.

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Report shows ‘troubling’ rise in colorectal cancer among US adults younger than 55 | CNN

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CNN
—

Adults across the United States are being diagnosed with colon and rectal cancers at younger ages, and now 1 in 5 new cases are among those in their early 50s or younger, according to the American Cancer Society’s latest colorectal cancer report.

The report says that the proportion of colorectal cancer cases among adults younger than 55 increased from 11% in 1995 to 20% in 2019. There also appears to be an overall shift to more diagnoses of advanced stages of cancer. In 2019, 60% of all new colorectal cases among all ages were advanced.

“Anecdotally, it’s not rare for us now to hear about a young person with advanced colorectal cancer,” said Dr. William Dahut, chief scientific officer for the American Cancer Society. For example, Broadway actor Quentin Oliver Lee died last year at 34 after being diagnosed with stage IV colon cancer, and in 2020, “Black Panther” star Chadwick Boseman died at 43 of colon cancer.

“It used to be something we never heard or saw this, but it is a high percentage now of colorectal cancers under the age of 55,” Dahut said.

Although it’s difficult to pinpoint a cause for the rise in colorectal cancers among younger adults, he said, some factors might be related to changes in the environment or people’s diets.

“We’re not trying to blame anybody for their cancer diagnosis,” Dahut said. “But when you see something occurring in a short period of time, it’s more likely something external to the patient that’s driving that, and it’s hard not to at least think – when you have something like colorectal cancer – that something diet-related is not impossible.”

The new report also says that more people are surviving colorectal cancer, with the relative survival rate at least five years after diagnosis rising from 50% in the mid-1970s to 65% from 2012 through 2018, partly due to advancements in treatment.

That’s good news, said Dr. Paul Oberstein, a medical oncologist at NYU Langone Perlmutter Cancer Center, who was not involved in the new report. The overall trends suggest that colorectal cancer incidence and death rates have been slowly declining.

“If you look at the overall trends, the incidence of colon cancer in this report has decreased from 66 per 100,000 in 1985 to 35 per 100,000 in 2019 – so almost half,” Oberstein said.

“Changes in the mortality rate are even more impressive,” he said. “In 1970, which was a long time ago, the rate of colorectal cancer death was 29.2 per 100,000 people, and in 2020, it was 12.6 per 100,000. So a dramatic, over 55% decline in deaths per 100,000 people.”

Colorectal cancer is the second most common cause of cancer death in the United States, and it is the leading cause of cancer-related deaths in men younger than 50.

Dahut said the best way to reduce your risk of colorectal cancer is to follow screening guidelines and get a stool-based test or a visual exam such as a colonoscopy when it’s recommended. Any suspicious polyps can be removed during a visual exam, reducing your risk of cancer.

“At the ACS, we recommend if you’re at average risk, you start screening at age 45,” Dahut said. “Usually, then your subsequent screening is based on the results of that screening test.”

For the new report, researchers at the American Cancer Society analyzed data from the National Cancer Institute and the US Centers for Disease Control and Prevention on cancer screenings, cases and deaths.

The researchers found that from 2011 through 2019, colorectal cancer rates increased 1.9% each year in people younger than 55. And while overall colorectal cancer death rates fell 57% between 1970 and 2020, among people younger than 50, death rates continued to climb 1% annually since 2004.

“We know rates are increasing in young people, but it’s alarming to see how rapidly the whole patient population is shifting younger, despite shrinking numbers in the overall population,” Rebecca Siegel, senior scientific director of surveillance research at the American Cancer Society and lead author of the report, said in a news release. “The trend toward more advanced disease in people of all ages is also surprising and should motivate everyone 45 and older to get screened.”

Some regions of the United States appeared to have higher rates of colorectal cancers and deaths than others. These rates were lowest in the West and highest in Appalachia and parts of the South and the Midwest, the data showed. The incidence of colorectal cancer ranged from 27 cases per 100,000 people in Utah to 46.5 per 100,000 in Mississippi. Colorectal cancer death rates ranged from about 10 per 100,000 people in Connecticut to 17.6 per 100,000 in Mississippi.

There were some significant racial disparities, as well. The researchers found that colorectal cancer cases and deaths were highest in the American Indian/Alaska Native and Black communities. Among men specifically, the data showed that colorectal cancer death rates were 46% higher in American Indian/Alaska Native men and 44% higher in Black men compared with White men.

The report also says that more left-sided tumors have been diagnosed, meaning an increasing percentage of tumors are happening closer to the rectum. The proportion of colorectal cancers in that location has steadily climbed from 27% in 1995 to 31% in 2019.

“Historically, we’ve been worried more about the tumors on what we call the right side,” said NYU Langone’s Oberstein.

“But the incidence increasing, especially among young people, seems to be happening not only in those worse tumors but the ones that we think are not as bad,” he said, referring to left-sided tumors. “It’s raising questions about whether something is changing about the risks and the future people who are going to get colon cancer.”

Looking forward, the researchers estimate that there will be 153,020 colorectal cancer cases diagnosed in the US this year and an estimated 52,550 colorectal cancer deaths, with 3,750 of them – or 7% – among people younger than 50.

“These highly concerning data illustrate the urgent need to invest in targeted cancer research studies dedicated to understanding and preventing early-onset colorectal cancer,” Dr. Karen Knudsen, CEO of the American Cancer Society, said in the news release. “The shift to diagnosis of more advanced disease also underscores the importance of screening and early detection, which saves lives.”

The report’s findings, including the rise in colorectal cancer in younger adults, are “troubling,” Dr. Joel Gabre, an expert in gastrointestinal cancers at Columbia University Irving Medical Center, said in an email.

“It reflects other recent published findings demonstrating a rising incidence of colorectal cancer in young people. Most concerning to me, however, is a lack of clear cause and patients being diagnosed late. I think this is an area where more funding for research is needed to understand this really concerning rise,” wrote Gabre, who was not involved in the report.

Gabre says he knows what it’s like to look into his young patients’ eyes and tell them they have colorectal cancer, and “it’s devastating.”

“They have young families and so much of their life ahead of them. That’s why I encourage my patients who are age 45 years and older to get screened,” Gabre said. “I also encourage people to let their doctor know if they have a family history of colon cancer. There is genetic testing we can do to identify some at-risk patients early before they develop cancer.”

The findings highlight the importance of colorectal cancer screening, Dr. Robin Mendelsohn, gastroenterologist and co-director of the Center for Young Onset Colorectal and Gastrointestinal Cancers at Memorial Sloan Kettering Cancer Center, said in an email.

“The age to start screening was recently decreased to 45, which will help in an effort to screen more people, but we still need to understand more why we are seeing this increase which is something we are actively looking into,” wrote Mendelsohn, was not involved in the new report.

Mendelsohn says she has seen an increase in advanced colorectal cancers and diagnoses among her younger patients, and she says to watch for symptoms such as rectal bleeding, abdominal pain and changes in bowel habits.

“Until we understand more, it is important that patients and providers recognize these symptoms so they can be evaluated promptly,” she said. “And, if you are at an age to get screened, please get screened.”

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Among seniors, Black men more likely to die after surgery than their peers, new study suggests | CNN

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CNN
—

Among older patients, Black men may have a higher chance of dying within 30 days following surgery than their peers, according to a new study.

The study, published Wednesday in the medical journal BMJ, suggests that this inequity could be driven by outcomes following elective surgery, for which death was 50% higher for Black men than for White men – information that can be helpful for physicians as they plan procedures for patients.

Previously, separate research published in 2020 came to similar findings among children, showing that, within 30 days from their surgeries, Black children were more likely to die than White children.

“While a fair bit is known about such inequities, we find in our analyses that it’s specifically Black men who are dying more, and they are dying more after elective surgeries, not urgent and emergent surgeries,” study lead Dr. Dan Ly, assistant professor of medicine in the division of general internal medicine and health services research at the David Geffen School of Medicine at the University of California, Los Angeles, said in a news release.

“Our findings point to possibilities such as poorer pre-optimization of co-morbidities prior to surgery, delays of care due to structural racism and physician bias, and worse stress and its associated physical burden on Black men in the United States,” Ly said in the news release.

Researchers at the University of California, Los Angeles analyzed Medicare data on more than 1.8 million beneficiaries, ages 65 to 99, who underwent one of eight common surgical procedures. The data came from 2016 to 2018, and the researchers examined how many patients died during their hospital stay or within 30 days after surgery.

The researchers found that dying after surgery overall was higher in Black men compared with White men, White women, and Black women. Dying after surgery was 50% higher for Black men than for White men after elective surgeries, the data suggest, but for non-elective surgeries, there was no difference between Black and White men, although mortality was lower for women of both races.

Among the Black men in the study, about 3% of them died following surgery overall compared with 2.7% of White men, 2.4% of White women and 2.2% of Black women. These differences were relatively larger for elective surgeries, and appeared within a week after surgery and persisted for up to 60 days after surgery, the researchers found. In a separate analysis, the researchers found that Hispanic men and Hispanic women showed a lower overall mortality than Black men.

“Our study has shed light on the fact that Black men experience a higher death rate after elective surgery than other subgroups of race and sex. Further research is needed to understand better the factors contributing to this observation, and to inform efforts to develop interventions that could effectively eliminate such disparity,” Dr. Yusuke Tsugawa, the senior author of the study and associate professor of medicine at UCLA David Geffen School of Medicine, said in an email.

The study did not explore what could be driving the disparity but Tsugawa said that “several factors” could potentially play a role.

“The structural racism may at least partially explain our findings. For example, Black patients living in neighborhoods with predominantly Black residents tend to live close to hospitals that lack resources to provide high quality healthcare,” Tsugawa said in the email. “It is possible that Black men in particular face especially high cumulative amounts of stress and allostatic load, which refers to the cumulative burden of chronic stress and life events, potentially leading to a higher death rate after surgery among this population.”

The new study “validates” that racial inequities exist in health care, said Dr. Georges Benjamin, executive director of the American Public Health Association, who was not involved in the study.

“Obviously it’s concerning when you see such a large disparity,” Benjamin said, referring to the differences in how many patients died after surgery in the study findings.

“Here’s another example that these disparities are real, and I think it helps inform people – physicians, health systems, providers of care – that the disparity is already there,” he said. “So, when they’re looking at providing surgical care to their patients, they should be informed that, statistically, some of their patients may not do well 30 days out after surgery, and so they need to put extra care in both providing care and understanding the health status of those patients when they go to surgery.”

The new study findings also raise many questions about health systems and what happens when a patient is discharged home after surgery and their ability to safely recover from a procedure, said Dr. Utibe Essien, assistant professor of medicine at the David Geffen School of Medicine at UCLA, who was not involved in the study.

“As a generalist, I’m really thinking about that part as well and how we can engage with our surgical colleagues to make sure our patients who are from underrepresented groups are leading healthy lives after they’ve gone under the knife so to speak,” Essien said, adding that more research could help determine which types of elective surgeries may have seen more significant disparities than other types – and what would be needed to reduce the disparities.

“Would we find something different with more rare, complicated surgeries? It’s possible and that goes back to the type of hospitals where patients are getting their care,” Essien said.

“How close is a hospital really connected to an academic medical center that knows the latest and greatest surgical procedures? Do they have the technology to be able to do some really innovative and safe work?” he said. “Looking into ways at the hospital level that we can address these disparities, I think, is going to be important.”

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11 minutes of daily exercise could have a positive impact on your health, large study shows | CNN

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Sign up for CNN’s Fitness, But Better newsletter series. Our seven-part guide up will help you ease into a healthy routine, backed by experts.

CNN
—

When you can’t fit your entire workout into a busy day, do you think there’s no point in doing anything at all? You should rethink that mindset. Just 11 minutes of moderate-to-vigorous intensity aerobic activity per day could lower your risk of cancer, cardiovascular disease or premature death, a large new study has found.

Aerobic activities include walking, dancing, running, jogging, cycling and swimming. You can gauge the intensity level of an activity by your heart rate and how hard you’re breathing as you move. Generally, being able to talk but not sing during an activity would make it moderate intensity. Vigorous intensity is marked by the inability to carry on a conversation.

Higher levels of physical activity have been associated with lower rates of premature death and chronic disease, according to past research. But how the risk levels for these outcomes are affected by the amount of exercise someone gets has been more difficult to determine. To explore this impact, scientists largely from the University of Cambridge in the United Kingdom looked at data from 196 studies, amounting to more than 30 million adult participants who were followed for 10 years on average. The results of this latest study were published Tuesday in the British Journal of Sports Medicine.

The study mainly focused on participants who had done the minimum recommended amount of 150 minutes of exercise per week, or 22 minutes per day. Compared with inactive participants, adults who had done 150 minutes of moderate-to-vigorous aerobic physical activity per week had a 31% lower risk of dying from any cause, a 29% lower risk of dying from cardiovascular disease and a 15% lower risk of dying from cancer.

The same amount of exercise was linked with a 27% lower risk of developing cardiovascular disease and 12% lower risk when it came to cancer.

“This is a compelling systematic review of existing research,” said CNN Medical Analyst Dr. Leana Wen, an emergency physician and public health professor at George Washington University, who wasn’t involved in the research. “We already knew that there was a strong correlation between increased physical activity and reduced risk for cardiovascular disease, cancer and premature death. This research confirms it, and furthermore states that a smaller amount than the 150 minutes of recommended exercise a week can help.”

Even people who got just half the minimum recommended amount of physical activity benefited. Accumulating 75 minutes of moderate-intensity activity per week — about 11 minutes of activity per day — was associated with a 23% lower risk of early death. Getting active for 75 minutes on a weekly basis was also enough to reduce the risk of developing cardiovascular disease by 17% and cancer by 7%.

Beyond 150 minutes per week, any additional benefits were smaller.

“If you are someone who finds the idea of 150 minutes of moderate-intensity physical activity a week a bit daunting, then our findings should be good news,” said study author Dr. Soren Brage, group leader of the Physical Activity Epidemiology group in the Medical Research Council Epidemiology Unit at the University of Cambridge, in a news release. “This is also a good starting position — if you find that 75 minutes a week is manageable, then you could try stepping it up gradually to the full recommended amount.”

The authors’ findings affirm the World Health Organization’s position that doing some physical activity is better than doing none, even if you don’t get the recommended amounts of exercise.

“One in 10 premature deaths could have been prevented if everyone achieved even half the recommended level of physical activity,” the authors wrote in the study. Additionally, “10.9% and 5.2% of all incident cases of CVD (cardiovascular disease) and cancer would have been prevented.”

Important note: If you experience pain while exercising, stop immediately. Check with your doctor before beginning any new exercise program.

The authors didn’t have details on the specific types of physical activity the participants did. But some experts do have thoughts on how physical activity could reduce risk for chronic diseases and premature death.

“There are many potential mechanisms including the improvement and maintenance of body composition, insulin resistance and physical function because of a wide variety of favorable influences of aerobic activity,” said Haruki Momma, an associate professor of medicine and science in sports and exercise at Tohoku University in Japan. Momma wasn’t involved in the research.

Benefits could also include improvement to immune function, lung and heart health, inflammation levels, hypertension, cholesterol, and amount of body fat, said Eleanor Watts, a postdoctoral fellow in the division of cancer epidemiology and genetics at the National Cancer Institute. Watts wasn’t involved in the research.

“These translate into lower risk of getting chronic diseases,” said Peter Katzmarzyk, associate executive director for population and public health sciences at Pennington Biomedical Research Center in Baton Rouge, Louisiana. Katzmarzyk wasn’t involved in the research.

The fact that participants who did only half the minimum recommended amount of exercise still experienced benefits doesn’t mean people shouldn’t aim for more exercise, but rather that “perfect shouldn’t be the enemy of the good,” Wen said. “Some is better than none.”

To get up to 150 minutes of physical activity per week, find activities you enjoy, Wen said. “You are far more likely to engage in something you love doing than something you have to make yourself do.”

And when it comes to how you fit in your exercise, you can think outside the box.

“Moderate activity doesn’t have to involve what we normally think of (as) exercise, such as sports or running,” said study coauthor Leandro Garcia, a lecturer in the school of medicine, dentistry and biomedical sciences at Queen’s University Belfast, in a news release. “Sometimes, replacing some habits is all that is needed.

“For example, try to walk or cycle to your work or study place instead of using a car, or engage in active play with your kids or grand kids. Doing activities that you enjoy and that are easy to include in your weekly routine is an excellent way to become more active.”

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Stem cell therapy may reduce risk of heart attack and stroke in certain heart failure patients, study shows | CNN

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CNN
—

Cell therapy, involving adult stem cells from bone marrow, has been shown to reduce the risk of heart attack and stroke in severe heart failure patients, according to a new study.

A single administration of adult stem cells directly into an inflamed heart, through a catheter, could result in a long-term 58% reduced risk of heart attack or stroke among heart failure patients with reduced ejection fraction, meaning they have a weakened heart muscle, suggests the study, published Monday in the Journal of the American College of Cardiology.

The study is being called the largest clinical trial of cell therapy to date in patients with heart failure, a serious condition that occurs when the heart can’t pump enough blood to meet the body’s needs.

“We followed these patients during several years – three years – and what we found was that their hearts got stronger. We found a very significant reduction in heart attack and stroke, especially in the patient that we measured in their blood that they had more inflammation going on,” said the study’s lead author Dr. Emerson Perin, a practicing cardiologist and medical director at The Texas Heart Institute in Houston.

“That effect, it was there across everyone, but for the patient that had inflammation, it was even more significant,” Perin said. “And there also is evidence that we had a reduction in cardiovascular deaths.”

The therapy involves injecting mesenchymal precursor cells into the heart. These particular stem cells have anti-inflammatory properties, which could improve outcomes in heart failure patients since elevated inflammation is a hallmark feature of chronic heart failure.

More than 6 million adults in the United States have chronic heart failure, and most are treated with drugs that address the symptoms of the condition. The patients included in the new study were all taking medications for heart failure, and the new research suggests that cell therapy can be beneficial when used in conjunction with heart failure drugs.

“You can imagine, we keep everybody going and doing better with the medicine. And now we have a treatment that actually addresses the cause and quiets everything down. So, this line of investigation really has a great future and I can see that, with a confirmatory trial, we can bring this kind of treatment into the mainstream,” Perin said.

“We can treat heart failure differently,” he said. “We have a new weapon against heart failure and this study really opens the door and leads the way for us to be able to get there.”

The new study – sponsored by Australian biotechnology company Mesoblast – included 565 heart failure patients with a weakened heart muscle, ages 18 to 80. The patients were screened between 2014 and 2019 and randomly assigned to either receive the cell therapy or a placebo procedure at 51 study sites across North America.

The patients who received the cell therapy were delivered about 150 million stem cells to the heart through a catheter. The cells came from the bone marrow of three healthy young adult donors.

The researchers, from The Texas Heart Institute and other various institutions in the United States, Canada and Australia, then monitored each patient for heart-related events or life-threatening arrhythmias.

Compared with the patients who received a sham procedure, those treated with the stem cell therapy showed a small but statistically significant strengthening of the muscle of the heart’s left pumping chamber within a year.

The researchers also found that the cell therapy decreased the risk of heart attack or stroke by 58% overall.

“This is a long-term effect, lasting an average of 30 months. So that’s why we’re so excited about it,” Perin said.

Among patients with high inflammation in their bodies, the combined reduced risk of heart attack or stroke was even greater, at 75%, the researchers found.

“These cells directly address inflammation,” Perin said.

“They have little receptors for these inflammatory substances – some of them are called interleukins, and there’s other kinds,” he said. “When you put them into an inflamed heart, it activates the cells and the cells go, ‘Wow, we need to respond. This house is on fire. We need to put out the fire.’ And so they then secrete various anti-inflammatories.”

The researchers wrote in their study that their findings should be considered as “hypothesis generating,” in that they show this cell therapy concept could work, but clinical trials would be needed to specifically confirm the effects of these stem cells on heart attack, stroke and other events. It is still unclear for how long the effects of the stem cell therapy last beyond 30 months and whether patients will need more stem cell injections in the future.

Overall, there were no major differences between the adverse events reported among the patients who received the cell therapy compared with those in the control group, and the researchers reported no major safety concerns.

“We’ve made an enormous step to be able to harness the real power of adult stem cells to treating the heart,” Perin said. “This trial really is a signal of a new era.”

For more than a decade, scientists have been studying potential stem cell therapies for heart failure patients – but more research is needed to determine whether this treatment approach could reduce the amount of hospitalizations, urgent care events or complications among patients with heart failure.

The new study didn’t find that, said cardiologist Dr. Nieca Goldberg, medical director of Atria New York City and clinical associate professor of medicine at NYU Grossman School of Medicine, who was not involved in the latest study.

What the new study did find is that “there may be a population of people that could benefit from the stem cell therapy, particularly people who have inflammation,” Goldberg said.

“It’s actually an interesting therapy, an interesting thing to consider, once more research substantiates its benefit. Because in heart failure, there’s multiple things going on and, particularly for the inflammatory component, this could be an interesting treatment,” she said. “It might have some role in heart failure patients with inflammation.”

The therapy’s effects on heart attack or stroke risks “were positive,” Dr. Brett Victor, a cardiologist at the Cardiology Consultants of Philadelphia, who was not involved in the study, said in an email.

“Specifically, patients who received the stem cell therapy were less likely to have a heart attack or stroke over the next 2.5 years, especially among those who were found to have a high degree of systemic inflammation as measured by a laboratory test,” Victor said in the email, adding that this represents how heart failure has a significant inflammatory component.

Those “positive signals” likely will be evaluated more in subsequent studies, Victor said.

“Current therapies for heart failure including lifestyle modifications, a growing list of excellent medications, and device therapies will continue to be the standard of care for treatment in the near-term,” he said. “I suspect that this trial will continue to move the field forward in studying cardiac cell therapy as we continue to look for ways to not just treat, but actually find a cure for this disease.”

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Zero-calorie sweetener linked to heart attack and stroke, study finds | CNN

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CNN
—

A sugar replacement called erythritol – used to add bulk or sweeten stevia, monkfruit and keto reduced-sugar products – has been linked to blood clotting, stroke, heart attack and death, according to a new study.

“The degree of risk was not modest,” said lead study author Dr. Stanley Hazen, director of the Center for Cardiovascular Diagnostics and Prevention at the Cleveland Clinic Lerner Research Institute.

People with existing risk factors for heart disease, such as diabetes, were twice as likely to experience a heart attack or stroke if they had the highest levels of erythritol in their blood, according to the study, published Monday in the journal Nature Medicine.

“If your blood level of erythritol was in the top 25% compared to the bottom 25%, there was about a two-fold higher risk for heart attack and stroke. It’s on par with the strongest of cardiac risk factors, like diabetes,” Hazen said.

Additional lab and animal research presented in the paper revealed that erythritol appeared to be causing blood platelets to clot more readily. Clots can break off and travel to the heart, triggering a heart attack, or to the brain, triggering a stroke.

“This certainly sounds an alarm,” said Dr. Andrew Freeman, director of cardiovascular prevention and wellness at National Jewish Health, a hospital in Denver, who was not involved in the research.

“There appears to be a clotting risk from using erythritol,” Freeman said. “Obviously, more research is needed, but in an abundance of caution, it might make sense to limit erythritol in your diet for now.”

In response to the study, the Calorie Control Council, an industry association, told CNN that “the results of this study are contrary to decades of scientific research showing reduced-calorie sweeteners like erythritol are safe, as evidenced by global regulatory permissions for their use in foods and beverages,” said Robert Rankin, the council’s executive director, in an email.

The results “should not be extrapolated to the general population, as the participants in the intervention were already at increased risk for cardiovascular events,” Rankin said.

The European Association of Polyol Producers declined to comment, saying it had not reviewed the study.

Like sorbitol and xylitol, erythritol is a sugar alcohol, a carb found naturally in many fruits and vegetables. It has about 70% of the sweetness of sugar and is considered zero-calorie, according to experts.

Artificially manufactured in massive quantities, erythritol has no lingering aftertaste, doesn’t spike blood sugar and has less of a laxative effect than some other sugar alcohols.

“Erythritol looks like sugar, it tastes like sugar, and you can bake with it,” said Hazen, who also directs the Cleveland Clinic’s Center for Microbiome and Human Health.

“It’s become the sweetheart of the food industry, an extremely popular additive to keto and other low-carb products and foods marketed to people with diabetes,” he added. “Some of the diabetes-labeled foods we looked at had more erythritol than any other item by weight.”

Erythritol is also the largest ingredient by weight in many “natural” stevia and monkfruit products, Hazen said. Because stevia and monkfruit are about 200 to 400 times sweeter than sugar, just a small amount is needed in any product. The bulk of the product is erythritol, which adds the sugar-like crystalline appearance and texture consumers expect.

The discovery of the connection between erythritol and cardiovascular issues was purely accidental, Hazen said: “We never expected this. We weren’t even looking for it.”

Hazen’s research had a simple goal: find unknown chemicals or compounds in a person’s blood that might predict their risk for a heart attack, stroke or death in the next three years. To do so, the team began analyzing 1,157 blood samples in people at risk for heart disease collected between 2004 and 2011.

“We found this substance that seemed to play a big role, but we didn’t know what it was,” Hazen said. “Then we discovered it was erythritol, a sweetener.”

The human body naturally creates erythritol but in very low amounts that would not account for the levels they measured, he said.

To confirm the findings, Hazen’s team tested another batch of blood samples from over 2,100 people in the United States and an additional 833 samples gathered by colleagues in Europe through 2018. About three-quarters of the participants in all three populations had coronary disease or high blood pressure, and about a fifth had diabetes, Hazen said. Over half were male and in their 60s and 70s.

In all three populations, researchers found that higher levels of erythritol were connected to a greater risk of heart attack, stroke or death within three years.

But why? To find out, researchers did further animal and lab tests and discovered that erythritol was “provoking enhanced thrombosis,” or clotting in the blood, Hazen said.

Clotting is necessary in the human body, or we would bleed to death from cuts and injuries. The same process is constantly happening internally, as well.

“Our blood vessels are always under pressure, and we spring leaks, and blood platelets are constantly plugging these holes all the time,” Hazen said.

However, the size of the clot made by platelets depends on the size of the trigger that stimulates the cells, he explained. For example, if the trigger is only 10%, then you only get 10% of a clot.

“But what we’re seeing with erythritol is the platelets become super responsive: A mere 10% stimulant produces 90% to 100% of a clot formation,” Hazen said.

“For people who are at risk for clotting, heart attack and stroke – like people with existing cardiac disease or people with diabetes – I think that there’s sufficient data here to say stay away from erythritol until more studies are done,” Hazen said.

Oliver Jones, a professor of chemistry at RMIT University in Victoria, Australia, noted that the study had revealed only a correlation, not causation.

“As the authors themselves note, they found an association between erythritol and clotting risk, not definitive proof such a link exists,” Jones, who was not involved in the research, said in a statement.

“Any possible (and, as yet unproven) risks of excess erythritol would also need to be balanced against the very real health risks of excess glucose consumption,” Jones said.

In a final part of the study, eight healthy volunteers drank a beverage that contained 30 grams of erythritol, the amount many people in the US consume, Hazen said, according to the National Health and Nutrition Examination Survey, which examines American nutrition each year.

Blood tests over the next three days tracked erythritol levels and clotting risk.

“Thirty grams was enough to make blood levels of erythritol go up a thousandfold,” Hazen said. “It remained elevated above the threshold necessary to trigger and heighten clotting risk for the following two to three days.”

Just how much is 30 grams of erythritol? The equivalent of eating a pint of keto ice cream, Hazen said.

“If you look at nutrition labels on many keto ice creams, you’ll see ‘reducing sugar’ or ‘sugar alcohol,’ which are terms for erythritol. You’ll find a typical pint has somewhere between 26 and 45 grams in it,” he said.

“My co-author and I have been going to grocery stores and looking at labels,” Hazen said. “He found a ‘confectionery’ marketed to people with diabetes that had about 75 grams of erythritol.”

There is no firm “accepted daily intake,” or ADI, set by the European Food Safety Authority or the US Food and Drug Administration, which considers erythritol generally recognized as safe (GRAS).

“Science needs to take a deeper dive into erythritol and in a hurry, because this substance is widely available right now. If it’s harmful, we should know about it,” National Jewish Health’s Freeman said.

Hazen agreed: “I normally don’t get up on a pedestal and sound the alarm,” he said. “But this is something that I think we need to be looking at carefully.”

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Beware the budget butt lift, regulators warn amid social media-inspired boom | CNN

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In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ruston was hospitalized due to infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

People like Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than three years later, data shows deaths still occur.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Dr. Bob Basu, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system nor insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Dr. Kevin Cairns proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Dr. Constantino Mendieta, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision, and the surgeon must use an ultrasound.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Dr. Mark Mofid, who co-authored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for post-surgical garments and devices.

“I ended up having to pay, like, $8,000,” Ruston said. A few days after Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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